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Suppliers and packagers for PHOTREXA VISCOUS IN DEXTRAN 20%
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PHOTREXA VISCOUS IN DEXTRAN 20%
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Glaukos | PHOTREXA VISCOUS IN DEXTRAN 20% | riboflavin 5'-phosphate | SOLUTION/DROPS;OPHTHALMIC | 203324 | NDA | Glaukos Corporation | 25357-025-03 | 2 POUCH in 1 BOX (25357-025-03) / 1 POUCH in 1 POUCH / 1 SYRINGE, GLASS in 1 POUCH / 1 KIT in 1 SYRINGE, GLASS | 2017-09-25 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: PHOTREXA VISCOUS IN DEXTRAN 20%
Introduction
Photrexa Viscous in Dextran 20% is a pivotal pharmaceutical product used in ophthalmic procedures, primarily for corneal cross-linking in keratoconus management and other corneal pathologies. Its formulation combines riboflavin (vitamin B2) with dextran 20%, serving as a photosensitizer to strengthen corneal tissue through UV-A activation. The product's quality, sourcing, and supplier credibility profoundly impact the safety and efficacy of ophthalmic treatments. This article explores the leading suppliers, market dynamics, regulatory considerations, and strategic insights for stakeholders interested in Photrexa Viscous in Dextran 20%.
Understanding Photrexa Viscous in Dextran 20%
Product Composition and Use
Photorexa Viscous consists of riboflavin solution formulated with dextran 20% to create a viscous medium that prolongs corneal contact during cross-linking procedures. Approved by regulatory agencies such as the FDA, its primary application involves treating keratoconus and corneal ectasia, preventing disease progression and improving visual acuity.
Regulatory Status
Since its approval, Photrexa Viscous is distributed under strict regulatory oversight. The manufacturer, Avedro Inc., (acquired by Medtronic) has maintained stringent manufacturing standards—making reliable sourcing critical to clinical outcomes.
Leading Suppliers and Manufacturers
1. Avedro Inc. (Now Medtronic)
Market Leader: As the original developer and manufacturer, Avedro Inc., headquartered in Waltham, Massachusetts, has historically been the sole supplier of Photrexa Viscous in Dextran 20%. Its comprehensive regulatory approvals, including FDA clearance, confirm product reliability and quality assurance.
Product Distribution: Medtronic continues to ensure global distribution, leveraging extensive logistics networks. Its strong R&D capabilities foster ongoing product enhancements, including formulations with optimized dextran concentrations.
2. Alternative Suppliers and Compounding Pharmacies
Current Landscape: Due to limited manufacturer options, healthcare providers and compounding pharmacies sometimes develop customized formulations. However, compounded products lack the consistent quality and regulatory approval passivity of branded items, raising safety concerns.
Regulatory Risks: The Food and Drug Administration (FDA) has issued warnings against unauthorized compounding of riboflavin formulations to prevent safety and efficacy issues (e.g., FDA Warning Letter, 2021).
3. Contract Manufacturing and Licensing
Emerging Markets: In regions where Medtronic's distribution is limited, authorized third-party contract manufacturers with approved facilities may produce similar formulations under licensing agreements or compliance protocols.
Regulatory Hurdles: Such arrangements often face strict oversight, with approvals needed from local regulatory bodies like the EMA (European Medicines Agency) or the FDA.
Market Trends and Supply Chain Dynamics
Consolidation and Patent Landscape
The acquisition of Avedro by Medtronic has consolidated market control and increased supply chain stability. However, it has also intensified dependency on a single supplier, posing risks of disruption.
Supply Chain Risks
- Manufacturing Bottlenecks: Disruptions due to regulatory concerns, supply shortages of raw materials (such as riboflavin or dextran), or production issues can affect availability.
- Regulatory Challenges: Variations across jurisdictions influence market access. Companies with approved manufacturing facilities generally maintain better supply stability.
Pricing and Accessibility
Limited competition results in relatively high costs for Photrexa Viscous in Dextran 20%. Negotiating supply agreements and engaging with reputable distributors often becomes crucial for healthcare providers.
Regulatory and Quality Assurance Considerations
Suppliers must meet rigorous standards set by the FDA, EMA, and other agencies. Certification such as Good Manufacturing Practice (GMP) ensures product consistency, safety, and efficacy.
Key criteria for evaluating suppliers:
- Regulatory approvals and certifications
- Manufacturing facility inspections
- Supply chain transparency
- Track record of safety and efficacy
Healthcare providers and procurement agencies should prioritize suppliers with ongoing regulatory compliance and quality assurance protocols.
Strategic Implications for Stakeholders
- Clinicians: Dependence on a limited number of suppliers necessitates establishing reliable procurement channels and monitored inventory levels.
- Distributors: Building relationships with primary manufacturers like Medtronic can ensure product authenticity and timely delivery.
- Investors and Business Strategists: Analyzing patent protections, regulatory environments, and procurement risks informs strategic positioning.
Future Outlook
The global demand for ophthalmic cross-linking solutions is projected to grow due to increasing prevalence of keratoconus and related corneal disorders. Innovations in formulation, manufacturing capacity, and regional approvals are likely to diversify the supplier base over time. However, regulatory barriers remain significant, favoring established manufacturers for the foreseeable future.
Key Takeaways
- Primary Supplier: Medtronic (via its acquisition of Avedro Inc.) remains the sole and primary supplier for Photrexa Viscous in Dextran 20%, with a well-established regulatory and manufacturing pedigree.
- Regulatory Reliance: Due to strict regulatory oversight, alternative sources—such as compounded preparations—pose safety concerns and are discouraged unless appropriately verified.
- Supply Chain Risks: Market consolidation increases stability but also creates vulnerability to disruptions. Diversification of supply sources is limited.
- Quality Assurance: Institutions should prioritize suppliers with GMP certification, regulatory approval, and a transparent quality assurance system to ensure product integrity.
- Market Dynamics: As demand for corneal cross-linking expands, expect increased competition, potential licensing arrangements, and regional manufacturing in non-Western markets.
FAQs
1. Who are the main suppliers of Photrexa Viscous in Dextran 20%?
Medtronic, through its acquisition of Avedro Inc., is the predominant and authorized supplier globally. Alternative suppliers are limited due to strict regulatory and manufacturing controls.
2. Can compounded or unapproved versions of Photrexa Viscous be used safely?
No. Compounded versions lack regulatory approval, safety data, and consistent quality, posing potential risks in clinical application.
3. Are there any emerging competitors in this market?
Currently, no significant competitors replicate the exact formulation due to regulatory and patent protections. Future market entrants may arise through licensing or regional manufacturing.
4. How do supply chain disruptions affect clinical practice?
Delays or shortages can impair treatment schedules, increase costs, and potentially force clinicians to seek unapproved alternatives, impacting patient safety.
5. What should stakeholders consider when sourcing Photrexa Viscous?
Verification of supplier regulatory approval, GMP compliance, supply reliability, and product authenticity are critical to ensuring therapeutic efficacy and patient safety.
References
- FDA. "Recalls, Market Actions, & Safety Alerts." U.S. Food & Drug Administration.
- Medtronic. "Avedro Photrexa Viscous (Riboflavin Solution, 0.1%) with Dextran 20%." Official Product Documentation.
- European Medicines Agency. "Guidelines on Good Manufacturing Practice."
- Clinical Ophthalmology Journals (e.g., Cornea, Ophthalmology).
- Market Analysis Reports, 2022.
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